Cardinal Health AirLife 006900 User manual

AirLife®nCPAP System
Operator’s & Routine Maintenance Manual
Driver Model 006900
Firmware Version 2.02
Latex Free
Cardinal Health
McGaw Park, IL 60085 USA
36-5031 Rev D
Distributed in Canada by
Source Medical Corporation
Mississauga, Ontario L4Z 4B9

Table of Contents
Product Description...............................................................2
Product Specification ............................................................3
Gas Supply ...................................................................................................... 3
Pressure Control / Monitoring .......................................................................... 3
Oxygen Control / Monitor................................................................................. 3
Flow Monitoring ............................................................................................... 3
Power Supply .................................................................................................. 3
Weight ............................................................................................................. 3
Dimensions...................................................................................................... 3
Pressure Relief ................................................................................................ 3
Flow Limit ........................................................................................................ 3
Alarm System .................................................................................................. 3
IEC 60601-1 Classification .............................................................................. 6
Storage and Operation Conditions .................................................................. 6
Driver Feature Diagram - Front Panel.............................................................. 7
Driver Feature Diagram - Back Panel .............................................................. 8
Warnings and Cautions Summary ........................................9
Operating Instructions ........................................................12
Driver Setup................................................................................................... 12
Interface Control Knob Operation .................................................................. 16
Standby Mode ............................................................................................... 17
Air or Oxygen Only Mode .............................................................................. 18
Trending ........................................................................................................ 18
System Operaton........................................................................................... 20
Final Checks and Routine Inspection ............................................................ 21
Icon Legend................................................................................................... 22
Alarm Details and Actions...................................................23
Cleaning and Routine Maintenance ....................................26
Unit Inspection and Cleaning......................................................................... 26
Disposal......................................................................................................... 28
Appendix A: Approved Accessories ....................................29
Appendix B: Electromagnetic Compatibility.........................30
Appendix C: Warranty Information ......................................35
Warranty ........................................................................................................ 35
Disclaimer...................................................................................................... 35
AirLife®nCPAP Operator’s Manual 1

Product Description
The AirLife®nCPAP System Driver is intended to provide continuous
positive airway pressure (CPAP) for use in hospitals to treat spontaneously
breathing newborns and infants with Respiratory Distress Syndrome (RDS),
or are recovering from RDS under the supervision of qualified personnel
(e.g., respiratory therapist or nurse). The driver operates on hospital or tank
air, and oxygen. The device has an internal battery and can be used for
intra-hospital transport, but is not intended for use in ambulances or aircraft.
The AirLife®nCPAP System Driver incorporates an electronic blender using
solenoid valves and servo controlled flow to maintain a user-set pressure
and FiO2. The system also utilizes a long-life oxygen sensor. The user
interface displays oxygen concentration, CPAP level, flow rate, trending, and
power and alarm conditions. The oxygen sensor automatically calibrates
every time the instrument is powered on. The driver is part of a larger
system that includes an nCPAP generator, fixation device, and patient
interface (prongs and/or masks).
2 AirLife®nCPAP Operator’s Manual

Product Specification
Gas Supply
41–66 psig (nominal 50 psig) clean, dry, medical air and oxygen. External
pressure regulators should be used if source pressures exceed 66 psig.
Pressure Control / Monitoring
Control Range: 2–10 cmH2O
Monitor Range: 1–11 cmH2O, accuracy ±1 cmH2O. Pressure is displayed as
<1 or >11 when outside this range.
Oxygen Control / Monitor
Control/Display Range: 21%–100% O2, accuracy ±3 percentage points
Monitor Range: 17%–104%O2, accuracy ±3 percentage points
Sensor Type: Long Life Ultrasonic (5+ years)
Flow Monitoring
Range: 0–15 LPM, accuracy ±10%
Power Supply
15 V DC, 3.3 A from included AC adapter (GlobTek, Inc. Model number
GTM21097-5015) or an internal 12 V sealed lead/acid battery. The battery
has a life of four (4) hours from a full charge (up to 16 hours required for
recharge).
Weight
Approx. 15 pounds
Dimensions
8 ½ x 8 ½ x 6 ½ inches (excluding gas inlets, patient outlets, and mounting
brackets)
Pressure Relief (2 systems)
Automatic electronic valve system preset to vent to ambient air when a High
Pressure alarm occurs
Mechanical internal relief valve preset to vent at 3 ±0.15 psig (211 ±11
cmH2O)
Flow Limit
Electronic flow limit to prevent the delivery flow from exceeding 3 LPM over
Target Flow or 15 LPM.
Alarm System
Alarms are delayed for 120 seconds after entering the main screen in order
to allow time for patient setup. If the patient setup takes longer than 120
seconds, the alarms can be muted for an additional 120 seconds by
pressing the alarm mute/reset button or the system can be placed into
Standby Mode.
AirLife®nCPAP Operator’s Manual 3

Supply Gas Pressure Alarm: An audible and visual Source Pressure
alarm will activate if the inlet pressure of one, or both, of the gas sources are
outside of the specified gas supply range. There is a 1 second delay for this
alarm. The alarm message will indicate the specific gas source that is out of
specification. If a single gas source goes out of range during operation, then
only the remaining gas source will be available (air or oxygen) and FiO2
blending will become inoperable. The user will be able to select either ‘Air
Only’ or ‘Oxygen Only’ to allow the unit to operate in single-gas source mode
and mute the FiO2alarms while the problem is corrected. The system will
automatically return to normal operation (blending to the original FiO2
setting) when the problem is corrected and the source pressures are
returned to within the specified range.
High Pressure Alarm: An audible and visual High Pressure alarm has dual
limits. The first limit will activate the alarm when the monitored pressure is
greater than or equal to 12 cmH2O for 2 seconds. The second limit will
activate the alarm immediately when the monitored pressure is greater than
or equal to 18 cmH2O. This alarm automatically activates the electronic
pressure relief solenoid and closes the patient delivery solenoid, which
instantly reduces the pressure in the patient circuit to zero. Approximately
every three (3) seconds, the system will reinstate flow. If the alarm condition
has cleared, the unit will operate normally. If the alarm condition still exists,
the ‘High Pressure’ alarm will cycle through the 3-second loop.
Elevated Pressure Alarm: An audible and visual Elevated Pressure alarm
is preset for a CPAP pressure that is 2 cmH2O above the Set CPAP level.
There is a 5 second delay for this alarm
Low Pressure Alarm: An audible and visual Low Pressure alarm is preset
for a CPAP pressure that is 2 cmH2O below the Set CPAP level. There is a
14 second delay for this alarm.
4 AirLife®nCPAP Operator’s Manual

Disconnect Alarm: An audible and visual ‘Disconnect’ alarm is preset to
detect a pressure line or patient interface that has come loose or that is
disconnected. The alarm is set to activate according to the following list:
Flow (LPM) CPAP (cmH2O)
≥0 ≤1
≥6 ≤2
≥9 ≤3
≥12 ≤4
≥14 ≤5
While the alarm is active, the patient flow will remain within ±2 LPM of Target
Flow. There is a 5 second delay for this alarm.
Leak Alarm: An audible and visual Leak alarm is preset for a flow rate that
is 3 LPM above the Target Flow rate or for a flow that is greater than 15
LPM. There is a 5 second delay for this alarm
Low Flow Alarm: An audible and visual Low Flow alarm is preset for flow
rates at or below 3 LPM. There is a 10 second delay for this alarm.
Oxygen Concentration Alarms: The oxygen concentration is allowed to
operate within a ±3 %O2range without alarming.
A Medium Priority warning will activate whenever the product of the variance
outside of the FiO2range and the duration (in seconds) of the variance
exceeds 20.
A High Priority alarm will activate whenever the product of the variance
outside of the FiO2range and the duration (in seconds) of the variance
exceeds 30.
For example: if the Set %O2is 30% and the reading is 35% for a period of
ten (10) seconds, a Medium Priority warning will activate. In this case the
reading is 2 percentage points outside of the ±3 percentage point range. If
the Set %O2is 30% and the reading is 35% for a period of 15 seconds, a
High Priority alarm will activate.
Battery Alarms: An audible and visual Low Battery alarm has dual limits.
The first limit will activate the medium priority alarm when the battery falls
below 10% remaining (approx. 24 minutes). The second limit will activate
the high priority alarm when the battery falls below 5% remaining (approx. 12
minutes). There is a 2 second delay for this alarm. An audible and visual
Charge Fault alarm will indicate if the battery is not charging properly. The
system verifies proper charging at start up and during the routine oxygen
calibration. There is a 5 second delay for this alarm.
AirLife®nCPAP Operator’s Manual 5

Oxygen Calibration Alarm: An audible and visual Oxygen Calibration
alarm will indicate if an oxygen sensor has failed to calibrate. If this alarm
occurs, remove patient and cycle the power for re-calibration or remove the
driver from service. While the alarm is active, the driver provides CPAP and
FiO2, however, the FiO2may not be accurate. The system calibrates the
oxygen sensor during start up and routinely during operation. There is no
delay for this alarm
Software Fault: An audible and visual Software Fault alarm will indicate
any software fault detected. The system will display a fault code which
should be recorded. If the fault is non-fatal, the alarm can be cleared and
the system will return to normal operation. If the fault is fatal, the driver will
need to have the power cycled or be removed from service. There is no
delay for this alarm
Flow / Pressure Sensor: A visual Sensor Calibration Fault will indicate if a
sensor has failed the calibration during the start up routine. A failure screen
will appear indicating what sensor has failed and informing the user to
remove the device from service.
IEC 60601-1 Classification
Internally Powered Equipment, Type BF, IPX 1
This equipment is rated for Continuous Operation.
Caution: Although the AirLife®nCPAP System Driver meets
the requirements of current EMC/RFI legislation, this does not
guarantee immunity from all sources of radiated energy. Some
mobile telephones and other products containing radio
transmitting components may cause a malfunction of the
AirLife®nCPAP driver and should not be used in the vicinity of
the driver.
Storage and Operating Conditions
•Safe for storage at -20°C–60°C
•Relative humidity of 15%–95% non-condensing
•Atmospheric pressure 0.6–1.4 Bar.
•Operating environment temperature is 5°C–40°C
•Keep dry and do not expose to direct sunlight
•This product meets the EMC requirements of IEC60601-1
Warning: The patient accessories for use with the AirLife®
nCPAP Driver are for single patient use only. Disposable
accessories include generators, fixation device, prongs,
masks, heated wire breathing circuits, and humidification
chambers. DO NOT STERILIZE OR REUSE.
6 AirLife®nCPAP Operator’s Manual

Driver Feature Diagrams
1
3 4 5 6
789101112
2
Figure 1: Front Panel Features
Item Description
1 Pressure LED Bar Graph (Indicates instantaneous patient pressure)
2 Pressure Display (Indicates average patient pressure)
3 Message Bar
4 FiO2Display
5 Alarm Priority LEDs and Alarm Mute
6 Alarm Mute/Reset Button
(Press & Release for Mute/Reset; Press & Hold for Standby Mode)
7 Power Status
8 Interface Control Knob
9 Trend Selection
10 Flow Display
11 Pressure Line Connection
12 Patient Connection
AirLife®nCPAP Operator’s Manual 7

Figure 2: Back Panel Features
1 2 3
456
7
8
Item Description
1 Power Connection
2 Fuse
3 Power Switch
(Switch does not disconnect driver from main power supply)
4 Oxygen Inlet
5 Water Trap and Air Filter (behind Air Inlet; not visible in this view)
6 Medical Air Inlet
7 Nationally Recognized Testing Laboratory (NRTL) Classification
8 Serial Number
8 AirLife®nCPAP Operator’s Manual

Warnings and Cautions Summary
The AirLife®nCPAP System Driver is intended to be operated only by
qualified personnel under the direction of a physician. The operator is
responsible for reading and thoroughly understanding the provided product
documentation.
Definitions to be considered throughout the document:
Warning: Used when the operator or the patient have the
possibility of being injured.
Caution: Used when the driver or accessories used with the
driver have the possibility of being damaged.
Note: Used for statements that could allow for more efficient or
convenient operation or service of the equipment.
The following are warnings, cautions, and notes that will appear within this
document. Please become familiar with their content.
Warning: The patient accessories for use with the AirLife®nCPAP
Driver are for single patient use only. Disposable accessories include
generators, fixation device, prongs, masks, heated wire breathing
circuits, and humidification chambers. DO NOT STERILIZE OR REUSE.
Warning: The driver should only be used after qualified personnel or a
technician has authorized it for use.
Warning: Oxygen vigorously accelerates combustion. To avoid an
explosion hazard, do not use any instrument or piece of equipment
that may have been exposed to oil or grease contamination.
Warning: To avoid the risk of fire or explosion, use this device in well-
ventilated areas away from flammable anesthetics.
Warning: When driver is connected to power source, keep cords clear
of walkways to avoid possible cord entanglement and strangulation.
Warning: Use this product only as directed in the product literature to
reduce the possibility of nasal and skin irritation, and necrosis.
AirLife®nCPAP Operator’s Manual 9

Warning: There is always a risk when using oxygen that the O2level in
the arterial plasma will reach an unacceptable level. This driver should
always be used in conjunction with a pulse oximeter to monitor patient
status. Oxygen toxicity can be a concern with this device for the
intended population if it is used for more than a few hours. Risks
include:
▪Absorption atelectasisi (collapse of lung tissue)
▪Hypercapnia (increased carbon dioxide)
▪Retrolental hyperplasia (which can cause blindness)
Also, Chemotherapy patients given bleomycin appear to be extremely
sensitive to even relatively low levels of oxygen.
Warning: The use of any power cords with the AirLife®nCPAP System
Driver other than those supplied with the driver may result in increased
emissions and/or decreased Immunity of the AirLife®nCPAP System
Driver.
Caution: Although the AirLife®nCPAP System Driver meets the
requirements of current EMC/RFI legislation, this does not guarantee
immunity from all sources of radiated energy. Some mobile telephones and
other products containing radio transmitting components may cause
malfunction of the AirLife®nCPAP System Driver and should not be used in
the vicinity of the driver.
Caution: Federal (USA) law restricts sale of this driver to, or on the order of,
a physician.
Caution: Any liquid introduced into the gas supplies will cause malfunction of
this driver and the equipment connected to it.
Caution: This driver is designed to mix oxygen and air only. Do not alter the
inlets for any other gas sources, such as anesthesia gases.
Caution: The power switch does not disconnect the driver from the main
power supply. This can only be accomplished by disconnecting the AC
adapter from either the driver or the AC outlet.
Caution: The correct AC adapter must be used with the driver. Use of an
incorrect AC adapter can damage the internal circuits of the driver.
Caution: Using the driver without the proper filters can allow dirt or moisture
to enter the system. This will damage the electronic blender, leaving the unit
non-operational.
Caution: Ensure that the driver is unplugged from external power and that
the power switch is in the “Off” position before cleaning.
10 AirLife®nCPAP Operator’s Manual

Caution: The driver will be damaged if any part of it is immersed in liquid or
gas, or steam sterilized.
Note: Alarms are delayed for 120 seconds after entering the main screen in
order to allow time for patient setup. If the patient setup takes longer than
120 seconds, the alarms can be muted for an additional 120 seconds by
pressing the alarm mute/reset button or the system can be placed into
Standby Mode.
Note: To enhance patient safety and comfort, use only with heated
humidifiers and heated wire circuits. The recommended setting is 37 °C,
100% RH.
Note: To obtain maximum battery life, it is recommended that the driver
remain connected to an external power source even when it is not in use.
Note: Class 1 LED product.
Note: Hospital personnel should keep records of Performance Verification
Tests and identify equipment that is authorized for use.
Note: The Driver must have both gases properly connected and within the
specified pressure range in order to pass the initial start-up sequence. This
will enable the Driver to perform a valid calibration and ensure accurate FiO2
delivery.
AirLife®nCPAP Operator’s Manual 11

Operating Instructions
The AirLife®nCPAP System is designed to provide an airway pressure that
is practically constant. The AirLife®generator utilizes vortice technology to
help reduce the patient’s imposed Work of Breathing. The Driver
automatically adjusts the gas flow rate to deliver the set CPAP level and
compensate for minor leaks in the system.
Caution: Federal (USA) law restricts sale of this driver to, or on
the order of, a physician.
Warning: The driver should only be used after qualified
personnel or a technician has authorized it for use.
Warning: Oxygen vigorously accelerates combustion. To
avoid an explosion hazard, do not use any instrument or
piece of equipment that may have been exposed to oil or
grease contamination.
Warning: To avoid the risk of fire or explosion, use this
device in well-ventilated areas away from flammable
anesthetics.
Driver Setup
1. Securely attach the driver to a stand or other mounting system that
includes a heater/humidification system. See Figure 3. A mounting plate
is included with the Driver and should be attached to the driver using the
supplied hardware. Ensure that the stand is rated to safely handle the
weight and dimensions of the driver, as detailed in “Product
Specification” on page 3.
Figure 3: The Driver Attached to a Stand
12 AirLife®nCPAP Operator’s Manual

Note: To enhance patient safety and comfort, use only with
heated humidifiers and heated wire circuits. The recommended
delivery is 37 °C, 100% RH.
2. Visually inspect the inlet air filter and water trap, located on the back of
the driver. See Figure 4. If the filter is dirty or wet, it must be cleaned or
replaced. A tool is included with the driver to assist in removing the
water trap.
A
ir Filter and Water Trap
Figure 4: Location of Air Filter and Water Trap
Caution: This driver is designed to mix oxygen and air only. Do
not alter the inlets for any other gas sources, such as
anesthesia gases.
Caution: Any liquid introduced into the gas supplies will cause
malfunction of this driver and the equipment connected to it.
Caution: Using the driver without the proper filters can allow
dirt or moisture to enter the system. This will damage the
electronic blender, leaving the unit non-operational.
3. Connect medical air and oxygen hoses to the back of the driver. See
Figure 5. Then connect the hoses to their respective high-pressure
sources.
Note: The Driver must have both gases properly connected and within
the specified pressure range in order to pass the initial start-up
sequence. This will enable the Driver to perform a valid calibration and
ensure accurate FiO2delivery.
AirLife®nCPAP Operator’s Manual 13

Medical Air
Inlet Oxygen Inlet
Figure 5: Air and Oxygen Connectors on Driver
• Plug the external power source into the power connector on the back of
the driver and an AC outlet. See Figure 6.
Power Connector
Figure 6: AC Power Connector on Driver
Warning: When driver is connected to power source, keep
cords clear of walkways to avoid possible cord
entanglement and strangulation.
Note: To obtain the maximum battery life, it is recommended
that the driver remain connected to the power source even
when not in use.
5. Power on unit and verify that all of the LEDs illuminate. See Figure 7.
14 AirLife®nCPAP Operator’s Manual

Figure 7: Illuminated LEDs
Note: Class 1 LED product.
6. Verify that the following default values are indicated on the main screen:
•CPAP Set: 5 cmH2O
•FiO2Set: 21% O2
•Flow Rate Target: 8 LPM
•Battery charging (lightning bolt in battery icon)
Note: Alarms are delayed for 120 seconds after entering the
main screen in order to allow time for patient setup. If the
patient setup takes longer than 120 seconds, the alarms can
be muted for an additional 120 seconds by pressing the alarm
mute/reset button or the system can be placed into Standby
Mode. See Figure 8.
Figure 8: Alarm Mute/Reset Button
7. Unplug external power, verify a single audible alarm burst sounds and
the interface indicates the driver is operating on battery power. Plug
external power source back in.
Caution: The power switch does not disconnect the driver from
the main power supply. This can only be accomplished by
disconnecting the AC adapter from either the driver or the AC
outlet.
AirLife®nCPAP Operator’s Manual 15

Interaction with Display Settings
Control of the various AirLife®nCPAP Driver features is accomplished
through the use of the Interface Control Knob.
Figure 9: Interface Control Knob
Interface Control Knob Operation
To adjust the %O2, CPAP, or Flow Target values, follow these steps.
1. Rotate the knob to move the highlight cursor to the different sections of
the screen. See Figure 10. The default location for the highlight cursor
is the Set %O2.
Figure 10: Main Display Screen
2. Select the parameter by pressing the knob when the section you wish to
change is highlighted.
3. A prompt will appear in the Message Bar at the top of the display
showing the current settings for that feature. Rotate the knob clockwise
to increase the value, counter-clockwise to decrease the value.
16 AirLife®nCPAP Operator’s Manual

Figure 11: Parameter Change Screen
When the desired value is displayed in the Message Bar, press the knob and
release to activate the new set value. The value will set only on the release,
not the press, of the knob. The change will automatically be canceled after
ten (10) seconds of inactivity and the previous setting will remain
unchanged.
4. The flow rate displayed on the LCD screen indicates the flow rate
exiting the patient outlet port. The “Target” flow is pre-set based on the
CPAP setting. The flow is automatically adjusted to maintain the CPAP
setting and it may normally vary from the Target flow.
5. The Driver will automatically increase flow up to 3 lpm above the Target
flow to compensate for normal leaks (i.e. leaks around prongs, masks,
or through the patient’s mouth).
• If a large leak exists at the patient, and cannot be corrected by
adjusting the patient interfaces, then the Target flow may be set
higher (up to 13 lpm) to provide more flow to compensate for
leaks. If the leak is resolved, the Driver will automatically reduce
the flow to maintain the set CPAP level.
• The flow rate should not be less than 3 lpm. A “low flow” alarm
will activate if the measured flow rate is less than 3 lpm and
would indicate a possible occlusion of the expiratory limb or a
defective circuit / generator. If this alarm occurs, check for
pinched or kinked tubing, or replace the circuit and / or generator.
Standby Mode
The AirLife®nCPAP System Driver has a Standby Mode to allow the
operator to mute the alarms for up to 20 minutes while at the bedside
attending to the patient. The mode is selected by pressing and holding the
Alarm Mute/Reset button until there is a single audible burst (approximately
3 seconds). The operator can exit the mode by pressing the Alarm
AirLife®nCPAP Operator’s Manual 17

Mute/Reset button or the system will automatically exit the mode and
resume normal operation after 20 minutes. While in Standby Mode the
system will operate normally with all audible alarms muted, with the
exception of High Pressure and Low Flow. To indicate that the system is in
Standby Mode, the Message Bar will display “Standby Mode” and the Alarm
Mute Leeds will flash. There will also be a single audible burst every two (2)
minutes while in Standby Mode. The driver will exit Standby Mode
automatically if a High Pressure or Low Flow alarm occurs.
Air or Oxygen Only Mode
While switching Air and Oxygen supply hoses from one source to another
(e.g. switching from tanks to wall sources), change one source at a time.
This will help prevent interruptions in fresh gas flow to the patient. The
AirLife®nCPAP System Driver may be used with a single gas source if one
gas source goes outside of the specified range (e.g. running out of gas)
during normal operation. During such an event, the Driver will alarm and
display the source fault in the Message Bar. In the absence of one gas
source, the patient can only receive air (FiO2~ 21%) or Oxygen (FiO2=
100%). If the fault cannot be corrected immediately, then the user may
select “Air Only” or “Oxygen Only” operation in order to mute the alarm while
the faulty gas source is corrected. When the faulty source pressure is
corrected, the system will automatically return to normal operation (alarms
will be delayed for 20 seconds) and blend gases to the previous set FiO2
value.
Trending
The AirLife®nCPAP System Driver has a trend screen. This screen will
display data for the previous 4, 8, 12, or 24 hours. Traces are displayed
simultaneously on the screen, see Figure 12. The trending screen will allow
the operator to know if there have been any fluctuations in the displayed
parameters. Information stored for the previous patient is automatically
removed when the unit is powered up.
18 AirLife®nCPAP Operator’s Manual